Cleveland, Ohio 44143


Purpose:

The purpose of this pilot study is to evaluate the effects of a theoretically-derived technology-based intervention (called TechSuPPorT) and its associated neurological mechanisms for hypertension self-management in African Americans. The investigators will compare two intervention arms in this study, the Technology-Based Component Only arm (comparison group) and the TechSuPPorT arm (intervention group) in 20 African Americans with uncontrolled hypertension. We aim to: 1. Determine whether there are differences in blood pressure (BP), health-related quality of life (HRQoL), and psychological health (affective well-being, depressive cognitions, anxiety) betweenTechSuPPorT and the Technology-based Component only arm. 2. Determine whether there are differences in self-management behaviors (medication adherence, diet, exercise, self-monitoring BP) between the two groups. 3. Examine whether self-efficacy, decision-making, motivation, patient activation, and perceived stress, and positive emotions mediate the relationship between the interventions and self-management behaviors. 4. Determine if social support, demographics (age, gender, education), discrimination, and technology utilization moderate self-management behaviors, BP, HRQoL, and psychological health. 5. Explore differences in neural processing (diffusion tensor imaging [DTI]/ task positive network [TPN] task-differentiation), and stress response (cortisol and inflammation panel) between the two groups.


Study summary:

The investigators will conduct a two-arm randomized clinical trial to compare the effects of an Technology-Based Component Only arm and TechSuPPorT on self-management behaviors, BP control, and HRQoL outcomeson cognitive task switching between the DMN and TPN neural networks using Functional Magnetic Resonance Imaging (fMRI) and Diffusion Tensor Imaging (DTI). Both groups will be exposed to the three Technology-based components: (a) six weekly web-based modules focused on improving African Americans' knowledge and skills of hypertension management; (b) personalized medication adherence support (SMS reminder messages, adherence feedback, health and lifestyle tips) through Medisafe, a smartphone app; and (c) self-monitor BP with study provided BP monitor. Participants in the TechSuPPorT arm will receive the three Technology-based components plus positive psychological training, a structured online training and skill building techniques to promote optimism, resilience, well-being, and self-confidence.


Criteria:

Inclusion Criteria: - self-identify as African American - 25 years and older - diagnosed with hypertension defined, as BP ≥ 130/80 mmHg - Taking at least one antihypertensive medication(s) - own an android smartphone - able to read and understand English Exclusion Criteria: - are unable to give informed consent or judged to have impaired cognitive ability or severe memory deficits - currently practicing positive psychological training - have a history of medical conditions or procedures that is contraindicated for fMRI scanning (cardiac pacemaker, sternal wires, or metal implants) - have a history of claustrophobia requiring anxiolytics or sedation - pregnant at time of enrollment


NCT ID:

NCT03722667


Primary Contact:

Principal Investigator
Carolyn H Still, PhD
University Hospitals Cleveland Medical Center

Carolyn H Still, PhD
Phone: 216-368-6338
Email: cwh11@case.edu


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44143
United States

Carolyn Still
Phone: 850-321-8807
Email: cwh11@case.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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